Boston Scientific Corp. (NYSE:BSX) won 510(k) clearance from the Food & Drug Administration and CE Mark approval in the European Union for its Advanix biliary stent.
The stent is designed to treat biliary strictures, abnormal narrowings of the common bile duct which can cause biliary stones and malignancies.
Natick, Mass.-based Boston Scientific said the new plastic biliary stent technology has improved deliverability and procedural control using the NaviFlex RX system, which the FDA cleared (PDF) along with the new stents. The regulatory clearances mean the devices are available in both the U.S. and European markets.
Boston Scientific managed to put some black ink on the books during the third quarter, despite posting a top-line slide of 5.4 percent.
The company posted profits of $190 million, or 12 cents per diluted share, on sales of $1.92 billion during the three months ended Sept. 30. That compares with a net loss of $94 million, or 6 cents per diluted share, on sales of $2.03 billion for Q3 2009.